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The cost is millions or billions. Pharma companies develop molecules that never even make it to the animal testing stage. Only one out of so many molecules make
by stef25 14y ago
The cost is millions or billions. Pharma companies develop molecules that never even make it to the animal testing stage. Only one out of so many molecules makes it to the market and brings in money. If it's discovered that, after perhaps a decade of animal, volunteer and patient testing the drug can not be marketed, the cost that went in to that needs to be recuperated from the next one that can be marketed. It's a very expensive process.
- Alex3917 14y ago"Pharma companies develop molecules that never even make it to the animal testing stage." In the US the vast majority of pre-clinical work is done by universities. Pharma companies usually license the patent from the universities once it is ready for clinical testing, under the Bayh-Dohl act:
- refurb 14y agoThis is incorrect. I would agree that universities do a large part of the basic science behind new drugs, but they do VERY little pre-clinical work (pretty much anything beyond simple receptor/enzyme bind studies). Pre-clinical work is done by CROs and biotech/pharma. The resources required to do pre-clinical work is enormous. Membrane barrier penetration, microsomal metabolism of drug product require a very large investment and there aren't any universities I know of that have large enough R&D programs to support it.
- Alex3917 14y agoInteresting. I'm guessing the pharma industry uses the term pre-clinical differently, I was just using it to mean anything that happens before clinical testing, which is how it's used in Wikipedia, Merriam-Websters, etc.
- refurb 14y agoNo, that's correct, pre-clinical is everything before actual clinical testing in humans. However, pre-clinical has many phases, of which university research institutes only participate in the earlier ones. Basic Research -> Lead -> Screen -> Hit -> Tox/ADME -> Formulation -> Phase I I would argue that education research institutes only participate in the first four activities. It's very rare for them to work at all in the Tox/ADME and formulation phases, which are incredibly complex and require a lot of resources and expertise they don't have.